510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K090367Substantially Equivalent

Se-601 Series Electrocardiograph

Edan Instruments, Inc., Yonkers NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090367 is the FDA 510(k) clearance record for SE-601 SERIES ELECTROCARDIOGRAPH, a class II device, cleared for Edan Instruments, Inc. on under FDA product code DPS (Electrocardiograph). FDA records list 94 510(k) clearances for Edan Instruments, Inc., from to . As of , FDA records show one recall naming K090367.

Clearance record

Decision date
Received
(110 days to decision)
Product code
DPS Electrocardiograph
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Applicant
Edan Instruments, Inc. 1 Odell Plz., Yonkers NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DPS

Trailing 12 months
6 clearances under product code DPS in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DPS, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20262
October 20260